Caplin Steriles Limited Receives USFDA Approval for Sodium Phosphates Injection USP

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Sodium Phosphates Injection USP, 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) Single-Dose Vials. This generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Hospira, Inc., USA (NDA 018892) is indicated as a source of phosphorus and for addition to large volume intravenous fluids. The product had total US sales of approximately $67 million for the 12-month period ending December 2025.